It is conventional to store drugs, vaccines, solutions and medicaments in a sealed vial or other container for later use. Such materials may be in a dry or powdered form to increase the shelf life and reduce inventory space. Such dry or powdered materials may be stored in a conventional sealed vial having an elastomeric stopper and reconstituted in liquid form for administration to a patient by adding a diluent or solvent. Alternatively, the material may be stored in liquid or even a gaseous form. A conventional vial for storing drugs, vaccines, medicaments and the like, generally includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper which generally includes a generally tubular portion inserted into the neck of the vial and a planar rim portion which overlies the vial rim. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial rim. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).
Recently, various vial transfer sets have been proposed for transferring fluid between a vial and a conventional syringe wherein the transfer set is mounted on the vial for later use. The proposed transfer sets, however, do not permit multiple uses of the transfer set, limiting their use to one application. The transfer set may include a piercing member, such as a needle cannula, generally telescopically mounted in a tubular fluid transfer member mounted on the open end of the vial. The transfer set may be enclosed by cup-shaped closure having a radial flange portion secured to the vial by malleable metal or plastic collar. Examples of such improved transfer sets include U.S. Pat. No. 6,003,566 assigned to the assignee of this application and pending application Ser. No. 09/168,502, filed Oct. 8, 1998 assigned to the assignee of this application, the disclosures of which are hereby incorporated by reference in their entirety.
As set forth above, however, the prior proposed vial transfer sets are not resealable and are therefore limited to a single use. U.S. Pat. Nos. 5,474,544, 5,549,651 and 5,697,915 disclose luer receiving medical valves having a slit silicone membrane and which eliminates the requirement for a needle cannula on the syringe, sometimes referred to as a “luer slip connector.” The medical valve disclosed in these patents are not, however, readily adaptable to a transfer set because the longitudinally slit cylindrical polymeric membrane must first be moved within the valve to a larger diameter chamber and then compressed by the luer slip connector of the syringe to expand and open the slit for transfer of fluid. Further, the luer receiving medical valve disclosed in these patents do not provide for piercing of a closure, such as the pierceable stopper of a conventional vial.
The need therefore remains for a universal transfer set suitable for use with a conventional sealed vial for transfer of fluids between a vial and a second container, such as a conventional syringe, whereby the transfer set is resealable for multiple applications. The resealable transfer set of this invention fulfills this need in a simple, reliable design, which is easily used by a healthcare worker. The resealable transfer set of this invention can be utilized to transfer fluids between a conventional vial having a conventional elastomeric stopper and a conventional syringe without a needle cannula. However, the improved resealable transfer set of this invention is universal in that it can be used to transfer any fluid between a first container having a pierceable closure and a second container.